Development and validation of a web-based patient decision aid for immunotherapy for patients with metastatic melanoma: study protocol for a multicenter randomized trial

Trials

Wolfgang Eich¹  Beate Wild¹  Christiane Bieber¹  Pia Grabbe¹  Kathrin M. Gschwendtner¹  Imad Maatouk¹  Julia Bossert²  Friedegund Meier³  Jessica C. Hassel⁴  Martin Salzmann⁴  Sophia B. Strobel⁴ 

[1] Department of General Internal Medicine and Psychosomatics, Center for Psychosocial Medicine, Heidelberg University Hospital, Thibautstraße 4, 69115, Heidelberg, Germany;Faculty of Medicine and University Hospital Cologne, University of Cologne, Köln, Germany;TAKEPART Media + Science, Köln, Germany;National Center for Tumor Diseases, University Hospital Dresden, Fetscherstraße 74, 01307, Dresden, Germany;National Center for Tumor Diseases, University Hospital Heidelberg, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany;

关键词: Melanoma;    Immunotherapy;    Patient decision aid;    Shared decision-making;    Randomized controlled trial;   

DOI  :  10.1186/s13063-021-05234-4

来源: Springer

【 摘 要 】

BackgroundPatients with metastatic melanoma and their physicians are confronted with a complex decision regarding first-line therapy. Risks and benefits vary considerably between various treatment options. With this in mind, we aim to develop and evaluate a patient decision aid (PtDA) to inform patients about the risks and benefits of treatment options, namely, immunotherapy as monotherapy, immunotherapy as combination therapy, and treatment with BRAF/MEK inhibitors. We aim to test whether the use of this PtDA before medical consultation will increase patients’ knowledge of treatment options and thus promote shared decision-making (SDM) and patient decision satisfaction.MethodsIn total, 128 patients with metastatic melanoma from two German cancer centers will be randomized to the intervention group (IG), receiving access to the PtDA before medical consultation, or the control group (CG), receiving treatment as usual (TAU), i.e., medical consultation alone. There will be three major assessment points (before intervention, T0; after intervention, T1; and 3 months after intervention, T2). The main outcome is the patient’s knowledge of their treatment options, measured by a self-developed, piloted multiple-choice test at T1. Secondary outcome measures will include the extent of SDM during medical consultation, assessed by Observer OPTION 5, and patient decision satisfaction, assessed by the Satisfaction with Decision Scale (SwD), at T1 and T2.DiscussionThis trial will assess the effectiveness of a developed PtDA to enhance patient knowledge of treatment options for metastatic melanoma, SDM, and patient decision satisfaction. If the efficacy can be proven, the PtDA will be implemented nationwide in Germany to close a relevant gap in the education and care of patients with metastatic melanoma.Trial registrationClinicalTrials.gov NCT04240717. Registered on 27 January 2020

【 授权许可】

CC BY